As a Regulatory Affairs Associate, you will Start a career with purpose - At GSK, we unite science, technology, and talent to get ahead of disease together. Our goal is to improve the lives of billions across the world. By bringing together outstanding people in an inclusive environment, we can make an impact on a global scale:
- Evaluation, preparation, coordination &submission of regulatory documents in compliance with local regulations
- Ensure regulatory compliance, timely submissions & secure regulatory approval in GNE markets.
- Managing all the internal processes between GNE-RA and the central team.
- Enable the company to achieve its objectives by obtaining marketing authorization approvals/ license maintenance on time.
- Strategic planning for life cycle maintenance.
- Liaising with different functional departments at the start of the project to provide early and broad visibility to upcoming projects for awareness, input and alignment.
- Communication and maintenance of product registration to ensure alignment with all stakeholders.
- Pharmacist in-charge responsibility in GSK multi-market warehouse hub.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Key Responsibilities:
- Liaising with different functional departments at the start of the project to provide early and broad visibility to upcoming projects for awareness, input and alignment. And to work with GRA and local teams thus ensuring local needs are considered in Global/Regional regulatory strategies which support the strategic planning process, local inputs to dossier development. Providing guidance on the approval processes to marketing colleagues within the region and providing regulatory input for launch planning. And providing regulatory and legislation insight to guide the development of business strategies.
- Responsible for completion of regulatory files for submission. (Prepare/Receive files and submit them to regulatory authorities within the defined and agreed submission/approval dates) and according to guidelines and Responsible for coordinating the MSRs to ensure right first time dossiers are provided for Manufacturing site registration and license maintenance.
- Establish effective communication and continuous follow-up with the external agencies & distributors to ensure timely submissions and approvals of all company’s applications including HAQs management. And circulate approval announcements.
- Providing artwork creation support to all GNE Markets, including follow up on translations if applicable, through using the supportive documents & complying with the company SOPs & local guidelines in a timely manner.Follow up to ensure that the locally manufactured/packaged artwork (if applicable) is compliant with the latest label updates. Authorize approval of technical changes in artwork/ GEXP updates.
- Maintenance of all lifecycle activities/ Product license details in Veeva by accurately updating all submissions and approval within the present global timelines -accountable for overall accuracy and compliance.
- Accountable for solving all supply issues related to regulatory activities and Review of regulatory information enclosed in technical terms of supply prepared by QA.
- Ensure alignment of regulatory objectives with GNE strategies, regional / global regulatory objectives and commercial plans
- To provide regulatory intelligence e.g. liaising with local market-based colleagues, professional staff at regulatory agencies etc to facilitate the review and approval of regulatory submissions. Help in shaping regulatory environments by shaping regulations.
- Update and maintenance of local and global databases supporting compliance and centralization of data within Regulatory Affairs. Management of documentation archiving and record keeping according to SOP and local legislation. Ensure compliance with company's SOPs and working practices for Good Regulatory Practice.
- Manage responsibility and operations if being the pharmacist in-charge for the GSK multi Market Warehouse Hub including but not limited to:
- Import permits and Export permits for controlled medicines to/from UAE and to other Gulf markets including controlled products
- Follow up on Strategic stock management of essential list
- SOP update and oversight adherence of MMW for controlled medicines.
- Maintenance of GSK-MMW's annual license of Good Storage & Distribution Practice (cGSDP}. Ensuring SOPs are in place, in use and updated with contribution in SOP development as needed for: Management of controlled products. Assessment of Storage & Distribution services provided by Third Part {GAC} and its implementation.
- License maintenance of GDSPs by Health Authority and preparation of external inspection.
- Cooperation with QA for SOP adherence and audit requirements
- Point of contact with HA for supply transaction queries related to GDSPs.
- Authentication with Signing off and stamping of CoAs for UAE market and MOH forms of export to all GNE markets as well as vaccines to Iran market. Obtain approval from UAE Regulatory Authority for destruction of controlled products in Non-country of origin.
- Update UAE Regulatory Authority with the monthly report of all transaction at MMW FZ Jebel Ali.
- Ensure smooth inspection on shipping by UAE-MOH-lnspector for export at MMW FZ Jebel Ali
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- UAE National.
- Bachelor of Pharmacy
- Entry Level – No Experience is required
- Excellent knowledge Microsoft office packages, word processing, access and outlook applications. High Performance Behaviors:
- Highly enthusiastic, self motivated, committed and dedicated personality.
- Positive attitude towards creating business solutions.
- Good communication skills (both verbal and in writing).
- Ability to work independently as well as in teamwork.
- Capacity to establish positive interpersonal relations and interact effectively with cross functional teams
- Capacity to work accurately under pressure to meet project timelines.
- High attention to details.
- Ability to work in a fast- paced, technically skilled, team setting.
Closing date:
19/02/2025
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Contact information:
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
